Hormone Therapy (Apalutamide) and Image-guided Stereotactic Body Radiation Therapy for the Treatment of Patients With Prostate Cancer, HEATWAVE Trial

NCT06067269 | Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: 23-000429NCI-2023-06647
• Study Type: interventional
• Target: 95
• Locations: 1 country
• Sites: 1

Brief Summary

This phase II trial evaluates apalutamide in combination with image-guided stereotactic body radiation therapy (SBRT) for the treatment of patients with prostate cancer. Prostate cancer usually needs the hormone testosterone to grow. Apalutamide is a hormone therapy that blocks the effect of testosterone on prostate tumor cells. This may help stop the growth of tumor cells that need testosterone to grow. Image-guided SBRT is a standard treatment for some types of prostate cancer. This treatment combines imaging of cancer within the body, with the delivery of therapeutic radiation doses produced on a linear accelerator machine. SBRT uses special equipment to position a patient and deliver radiation to tumors with high precision. This method may kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. Combining apalutamide with image-guided SBRT may increase a prostate cancer patient's chances of achieving an extremely low prostate specific antigen response, which is an early predictor of disease cure.

Conditions

Prostate Adenocarcinoma; Stage II Prostate Cancer AJCC v8; Stage IIIA Prostate Cancer AJCC v8; Stage IIIB Prostate Cancer AJCC v8

Outcome Measures

Primary Outcomes (1)

• Percent of patients achieving prostate specific antigen (PSA) of < 0.2 ng/mL

  Will be summarized by count and percent along with the 95% confidence interval. This will then be compared to the historical control rate of 70% using a two sample z test for proportions with a one-sided p-value threshold of 0.05.

  Three months after completion of apalutamide

Secondary Outcomes (7)

• Time to biochemical recurrence (BCR)

  We will follow patients for five years following completion of radiotherapy. Biochemical disease status will be checked every 3 months for the first year, and every 6 months thereafter.

• Patient-reported outcomes (PROs) on the Expanded Prostate Cancer Index Composite-26 (EPIC-26) urinary domain

  24 months after completion of stereotactic body radiation therapy (SBRT)

• PROs on the EPIC-26 bowel domain

  24 months after completion of SBRT

• Radiographic persistence of disease on prostate specific membrane antigen (PSMA) positron emission tomography/computed tomography (PET/CT)

  6 months after hormonal therapy completion

• Radiographic persistence of disease on multiparametric magnetic resonance imaging

  At 6 months, 12 months, 18 months, 24 and 30 months after radiotherapy completion

Study Arms (1)

Treatment (apalutamide, SBRT)

EXPERIMENTAL

Patients receive apalutamide PO QD on days 1-28 of each cycle. Cycles repeat every 28 days for up to 6 or 12 months in the absence of disease progression or unacceptable toxicity. Patients undergo SBRT for 5 fractions over 1-2 weeks beginning on day 1 of cycle 1. Patients also undergo multiparametric MRI and collection of blood samples throughout the trial. Patients undergo PSMA-PET/CT scans during screening and follow up.

Drug: Apalutamide; Procedure: Biospecimen Collection; Procedure: Computed Tomography; Other: Gallium Ga 68 Gozetotide; Radiation: Guided Stereotactic Body Radiation Therapy; Procedure: Multiparametric Magnetic Resonance Imaging; Procedure: Positron Emission Tomography; Other: Questionnaire Administration

Interventions

Apalutamide DRUG

Given PO

Also known as: ARN 509, ARN-509, ARN509, Erleada, JNJ 56021927, JNJ-56021927

Treatment (apalutamide, SBRT)

Biospecimen Collection PROCEDURE

Undergo collection of blood samples

Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection

Treatment (apalutamide, SBRT)

Computed Tomography PROCEDURE

Undergo PSMA-PET/CT

Also known as: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized axial tomography (procedure), Computerized Tomography, CT, CT Scan, tomography

Treatment (apalutamide, SBRT)

Gallium Ga 68 Gozetotide OTHER

Undergo PSMA-PET/CT

Also known as: (68)Ga labeled Glu-NH-CO-NH-Lys(Ahx)-HBED-CC, (68)Ga-labeled Glu-urea-Lys(Ahx)-HBED-CC, (68)Ga-PSMA Ligand Glu-urea-Lys(Ahx)-HBED-CC, (68)Gallium-PSMA Ligand Glu-urea-Lys(Ahx)-HBED-CC, (68Ga)Glu-urea-Lys(Ahx)-HBED-CC, 68Ga-DKFZ-PSMA-11, 68Ga-HBED-CC-PSMA, 68Ga-labeled Glu-NH-CO-NH-Lys(Ahx)-HBED-CC, 68Ga-PSMA, 68Ga-PSMA-11, 68Ga-PSMA-HBED-CC, [68Ga] Prostate-specific Membrane Antigen 11, [68Ga]GaPSMA-11, AAA 517, AAA-517, AAA517, Ga PSMA, Ga-68 labeled DKFZ-PSMA-11, Ga-68 labeled PSMA-11, GA-68 PSMA-11, Gallium Ga 68 PSMA-11, Gallium Ga 68-labeled PSMA-11, GALLIUM GA-68 GOZETOTIDE, Gallium-68 PSMA, Gallium-68 PSMA Ligand Glu-urea-Lys(Ahx)-HBED-CC, GaPSMA, PSMA-HBED-CC GA-68

Treatment (apalutamide, SBRT)

Guided Stereotactic Body Radiation Therapy RADIATION

Undergo guided SBRT

Treatment (apalutamide, SBRT)

Multiparametric Magnetic Resonance Imaging PROCEDURE

Undergo multiparametric MRI

Also known as: MP-MRI, mpMRI, Multi-parametric MRI, Multiparametric MRI

Treatment (apalutamide, SBRT)

Positron Emission Tomography PROCEDURE

Undergo PSMA-PET/CT

Also known as: Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure), Positron Emission Tomography Scan, Positron-Emission Tomography, proton magnetic resonance spectroscopic imaging, PT

Treatment (apalutamide, SBRT)

Questionnaire Administration OTHER

Ancillary studies

Treatment (apalutamide, SBRT)

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Confirmed diagnosis of prostate adenocarcinoma
• Age ≥ 18
• Classified as having National Comprehensive Cancer Network unfavorable intermediate risk prostate cancer (i.e., \[a\] 2 of the following: PSA 10-20 ng/mL, clinical T category 2b-2c, or International Society of Urological Pathology \[ISUP\] grade group 2; \[b\] OR any 1 of \[a\] with ISUP grade group 3 disease; OR \[c\] any 1 of \[a\] with 50% or more cores on systematic biopsy showing prostate cancer)
• Have a Decipher genomic classifier score
• Have at least one dominant intraprostatic lesion visible on multiparametric MRI (Prostate Imaging-Reporting and Data System \[PI-RADS\] version 2.1 score 4 or 5)
• Have underwent a prostate specific membrane antigen (PSMA) positron emission tomography/computed tomography (PET/CT)
• Have total testosterone \>= 150 ng/dL
• Adequate performance status (Eastern Cooperative Oncology Group \[ECOG\] 0-1)
• Hemoglobin ≥ 9.0 g/dL, independent of transfusion and/or growth factors within 3 months prior to randomization (at screening)
• Platelet count ≥ 100,000 x 10\^9/uL independent of transfusion and/or growth factors within 3 months prior to randomization (at screening)
• Serum albumin ≥ 3.0 g/dL (at screening)
• Glomerular filtration rate (GFR) ≥ 45 mL/min (at screening)
• Serum potassium ≥ 3.5 mmol/L (at screening)
• Serum total bilirubin ≤ 1.5 x upper limit of normal (ULN) (Note: In subjects with Gilbert's syndrome, if total bilirubin is \> 1.5 x ULN, measure direct and indirect bilirubin and if direct bilirubin is ≤ 1.5 x ULN, subject may be eligible) (at screening)
• Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \< 2.5 x ULN (at screening)

You may not qualify if:

• Any evidence of spinal cord compression (radiological or clinical)
• Prior pelvic malignancy
• Prior pelvic radiation
• Concurrent malignancy other than adequately treated basal cell or squamous cell skin cancer, non-muscle invasive bladder cancer (NMIBC), or any other cancer in situ currently without evidence of recurrence or progression
• Inability to undergo radiotherapy, or hormonal therapy
• Primary small cell carcinoma of the prostate (prostate adenocarcinoma with neuroendocrine differentiation is allowed)
• Inflammatory bowel disease or active collagen vascular disease
• History of any of the following:
• Seizure or known condition that may pre-dispose to seizure (e.g. prior stroke within 1 year to randomization, brain arteriovenous malformation, Schwannoma, meningioma, or other benign central nervous system \[CNS\] or meningeal disease which may require treatment with surgery or radiation therapy)
• Severe or unstable angina, myocardial infarction, symptomatic congestive heart failure, arterial or venous thromboembolic events (eg, pulmonary embolism, cerebrovascular accident including transient ischemic attacks), or clinically significant ventricular arrhythmias within 6 months prior to randomization
• Current evidence of any of the following:
• Uncontrolled hypertension
• Gastrointestinal disorder affecting absorption
• Known active infection (eg, human immunodeficiency virus \[HIV\] or viral hepatitis)
• Any condition that in the opinion of the investigator would preclude participation in this study

Sponsors & Collaborators

• Jonsson Comprehensive Cancer Center: lead
• Janssen Scientific Affairs, LLC: collaborator

Study Sites (1)

UCLA / Jonsson Comprehensive Cancer Center

Los Angeles, California, 90095, United States

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

apalutamide; Specimen Handling; gallium 68 PSMA-11; 68Ga-DKFZ-PSMA-11; Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Spectrum Analysis; Chemistry Techniques, Analytical

Study Officials

• Amar Kishan

  UCLA / Jonsson Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christy Palodichuk

CONTACT

310-267-8988; cpalodichuk@mednet.ucla.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2023
• First Posted: October 4, 2023
• Study Start: March 28, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: July 15, 2025

Record last verified: 2025-07

Locations

US (1)